Effect of Ivermectin 600 μg/kg for 6 days vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate COVID-19: A Randomized Clinical Trial
MD, MHS Susanna Naggie, MD, MPH David R Boulware, PhD Christopher J Lindsell, PhD Thomas G Stewart, MD Stephen C Lim, MD Jonathan Cohen, MD David Kavtaradze, MD Arch P Amon, MD Ahab Gabriel, MD Nina Gentile, MD, MHS G Michael Felker, MD, DPP Russell L Rothman, MD Dushyantha Jayaweera, MD Matthew W Mccarthy, MD Mark Sulkowski, RN Sybil Wilson, BS Allison Delong, BA April Remaly, MS Rhonda Wilder, MD, MSci Sean Collins, PhD Sarah E Dunsmore, PhD Stacey J Adam, Florence Thicklin, MD George J Hanna, MD, MPH Adit A Ginde, MD, MPH Mario Castro, MD, MPH, MS Kathleen Mctigue, PhD Elizabeth Shenkman, MD, MHS Adrian F Hernandez
doi:10.1101/2022.12.15.22283488
Background: Whether ivermectin, with a maximum targeted dose of 600 µg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains unknown. Our objective was to evaluate the effectiveness of ivermectin, dosed at 600 µg/kg, daily for 6 days compared with placebo for the treatment of early mild to moderate COVID-19. Methods: ACTIV-6, an ongoing, decentralized, randomized, double-blind, placebo-controlled, platform trial, was designed to evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A total of 1206 participants age ≥30 years with confirmed COVID-19, experiencing ≥2 symptoms of acute infection for ≤7 days, were enrolled from February 16, 2022,
Author Contributions Drs Naggie and Hernandez had full access to all of the blinded data in the study. Drs Lindsell and Stewart directly accessed and verified the underlying study data and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the drafting and review of the manuscript and agreed to submit for publication.
Disclosures
Data Sharing Statement Available in the Supplement to the ACTIV-6 Statistical Analysis Plan (Supplement 4).
(C) Caption: Thick vertical lines denote the estimated mean of the posterior distribution. Density is the relative likelihood of posterior probability distribution. Outcomes with higher density are more likely than outcomes with lower density.
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